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NCT04370340 Clinical Trial

Application of a Perineal Protection Device in Vacuum-assisted Births

Perineal Tear Clinical Trial

Official title:
Application of a Perineal Protection Device in Vacuum-assisted Births: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04370340
Other study ID # PeriProtectTrial
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1, 2020
Est. completion date September 30, 2022

Study information
Verified date November 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support. The medical device "BabySlide®" was developed as an auxilliary device for perineal support and already evaluated in a multicenter randomized controlled trial in Schweden in pregnant women during vaginal birth. It could be seen, that the application of the device significantly reduced the rate of vagibal tears and low-grade perineal tearsin the intervention group (with application of the BabySlide®) in contrast to the controlo group (without application of the BabySlide®) by about 10%. In this study, solely 10% of births were ended by vacuum assistance. However, birth tears appear much more often in vacuum-assisted births than in normal spontaneous births. Therefore, the aim of this study is to evaluate the application of the device explicitly in vacuum-assisted births and to investigate if the application should be recommende in vacuum extractions in general in the future.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Schwangere Frauen ab 18 Jahren - Schwangerschaftsalter ab 36+0 SSW bei Geburt - Einlingsschwangerschaft - Schädellage des Kindes bei Geburt - Anstreben einer Vaginalgeburt am USZ - Geburtsbeendigung per Vakuumextraktion (Saugglocke) - Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung (ausreichende Deutsch- bzw. Englischkenntnisse) Exclusion Criteria: - - Geburtsbeendigung per Spontangeburt, Forcepsextraktion (Zange) oder Sectio caesarea (Kaiserschnitt) - Maternale Erkrankung des Bindegewebes (z.B. Kollagenosen) - Äusserliche fetale Fehlbildungen, die den Geburtsablauf und die Grössenverhältnisse von Kind zu Geburtskanal verändern - Intrauteriner Fruchttod des Kindes - Vaginale, perineale und/oder vulväre Voroperationen (ausser Naht von Geburtsverletzungen) - St.n. Beckenboden-Operation oder Inkontinenz-Operation - St.n. Infibulation - Anwendung des EPI-NO® Dammtrainers während der Schwangerschaft - Bekannte Allergien gegenüber einem der Inhaltsstoffe des BabySlide®

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BabySlide
Application of BabySlide during vacuum-assisted births for perineal protection

Locations
Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of vaginal tears assessment of the rate of vaginal tears in the posterior compartment by inspection at day of birth
Primary rate of low-grade perineal tears assessment of the rate of low-grade perineal tears by inspection at day of birth
Secondary rate of high-grade perineal tears assessment of the rate of high-grade perineal tears by inspection at day of birth
Secondary Maternal adverse effects assessment of maternal adverse effects of the BabySlide by medical staff within 1-4 days after birth
Secondary Fetal adverse effects assessment of fetal adverse effects of the BabySlide by medical staff within 1-4 days after birth
Secondary Maternal comfort with the BabySlide Assessment of maternal comfort with the BabySlide by a questionnaire within 1-4 days after birth
Secondary User abilitiy Assessment of the user ability of the BabySlide by a questionnaire directly after the procedure
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